An Efficacy and Safety Study of PH-10 Aqueous Hydrogel for the Treatment of Plaque Psoriasis

• ClinicalTrials.gov Identifier: NCT00941278
• Recruitment Status: Completed
• First Posted: July 17, 2009
• Last Update Posted: July 7, 2010
• Sponsor: Provectus Pharmaceuticals
• Information provided by: Provectus Pharmaceuticals

Study Description

Brief Summary:

PH-10 is an aqueous hydrogel formulation of rose bengal disodium (RB) for topical administration to the skin, and is being studied for the treatment of cutaneous skin disorders, specifically psoriasis and atopic dermatitis. This phase 2 efficacy and safety study will assess topical PH-10 applied once daily to areas of mild to moderate plaque psoriasis.

Condition or disease	Intervention/treatment	Phase
Psoriasis	Drug: PH-10 (0.001% Rose Bengal)	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: July 2009
• Actual Primary Completion Date: December 2009
• Actual Study Completion Date: April 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: PH-10 Treatment	Drug: PH-10 (0.001% Rose Bengal); PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.

Outcome Measures

Primary Outcome Measures :

1. The primary efficacy endpoint is "Treatment Success," a static endpoint assessed at Day 29 after initial PH-10 treatment and defined as 0 or 1 on all Psoriasis Severity Index (PSI) components and 0 or 1 on the Plaque Response scale. [ Time Frame: 28 days ]
2. The primary safety endpoint is incidence of adverse experiences, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality). [ Time Frame: 8 weeks ]

Secondary Outcome Measures :

1. Psoriasis Severity Index (PSI) score changes at each visit from Day 1 pre-treatment. [ Time Frame: 8 weeks ]
2. Plaque Response score changes at each visit from Day 1 pre-treatment. [ Time Frame: 8 weeks ]
3. Pruritus Self-Assessment score changes at each visit from Day 1 pre-treatment. [ Time Frame: 8 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Men or women, age 18 or older.
• Presence of mild to moderate plaque psoriasis on the trunk or extremities (excluding palms, soles, scalp, and facial or intertriginous areas).
• Fitzpatrick skin type I-VI.
• Written informed consent by the subject or legal guardian.

Exclusion Criteria:

• Women of childbearing potential who are pregnant, attempting to conceive, not using effective contraception, or who are nursing an infant.
• Subjects who have received PUVA or systemic antipsoriatic therapy (immunosuppressants, cytostatics, corticosteroids) within 28 days of study initiation (two weeks for methotrexate).
• Subjects who have received UVB light therapy within 14 days of study initiation.
• Subjects who have received topical antipsoriatic therapy (including corticosteroids, tar, anthralin or Vitamin D analogs) to the study plaque areas within 14 days of study initiation.
• Subjects who have received agents posing a clinically significant risk of photosensitivity reaction within 5 half-lives of study initiation.
• Subjects who have received any approved or investigational biologic drug therapy for psoriasis within 90 days or 5 half-lives of study initiation.
• Subjects who have participated in a clinical research study within 28 days of study initiation.
• Subjects with a history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum.
• Subjects with clinical conditions that, in the opinion of the Investigator may pose a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject.

Contacts and Locations

Locations

United States, Florida

International Dermatology Research

Miami, Florida, United States, 33144

United States, New York

Mount Sinai School of Medicine

New York, New York, United States, 10029

Sponsors and Collaborators

Provectus Pharmaceuticals

Investigators

• Study Director: Eric Wachter, PhD; Provectus Pharmaceuticals

More Information

• Responsible Party: Eric Wachter/Vice President, Provectus Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00941278
• Other Study ID Numbers: PH-10-PS-22
• First Posted: July 17, 2009
• Last Update Posted: July 7, 2010
• Last Verified: July 2010

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases